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Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure (SOHO)

P

Poitiers University Hospital

Status

Enrolling

Conditions

Hypoxemic Respiratory Failure
Acute Respiratory Failure

Treatments

Other: Standard oxygen
Other: High-flow nasal oxygen therapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

First-line therapy of patients with acute respiratory failure consists in oxygen delivery through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not recommended. In a large randomized controlled study, high-flow nasal oxygen has been described as superior to non-invasive ventilation and standard oxygen in terms of mortality but not of intubation. Paradoxically in immunocompromised patients, high-flow nasal oxygen has not been shown to be superior to standard oxygen. To improve the level of evidence of daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen, in terms of mortality in all patients with acute hypoxemic respiratory failure

Enrollment

1,110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All consecutive patients older than 18 years with an acute hypoxemic respiratory failure will be enrolled if they meet all the following criteria:

  • Respiratory rate >25 breaths/min whatever the oxygen support
  • Pulmonary infiltrate,
  • PaO2/FiO2 ≤200 mmHg
  • Informed consent from the patient or relatives.

Exclusion criteria

  • PaCO2 > 45 mm Hg
  • Need for emergent intubation: pulse oximetry < 90% with maximum oxygen support, respiratory arrest, cardiac arrest, or Glasgow coma scale below 8 points
  • Hemodynamic instability defined by signs of hypoperfusion or use of vasopressors > 0.3 µg/kg/min
  • Glasgow coma scale equal to or below 12 points
  • Exacerbation of chronic lung disease including chronic obstructive pulmonary disease (grade 3 or 4 of Gold classification), or another chronic lung disease with long term oxygen or ventilatory support
  • Cardiogenic pulmonary edema as main reason for acute respiratory failure
  • Coronavirus SARS-2 infection as reason for acute respiratory failure (the SOHO-COVID study has been completed)
  • Post-extubation respiratory failure within 7 days after extubation,
  • Post-operative patients within 7 days after abdominal or cardiothoracic surgery,
  • Do not intubate order;
  • Already included in the study, refusal to participate or participation in another interventional study with the same primary outcome.
  • Patients without any healthcare insurance scheme or not benefiting from it through a third party,
  • Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,110 participants in 2 patient groups

standard oxygen group
Active Comparator group
Description:
In order to maintain SpO2 between 92 and 96%
Treatment:
Other: Standard oxygen
high-flow nasal cannula oxygen group
Experimental group
Description:
At least 50 L/min adjusted in order to maintain SpO2 between 92 and 96 %
Treatment:
Other: High-flow nasal oxygen therapy

Trial contacts and locations

1

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Central trial contact

Céline DELETAGE, PhD; Jean-Pierre FRAT, PhD

Data sourced from clinicaltrials.gov

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